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Generated: September 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078069

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NDA 078069 describes OXCARBAZEPINE, which is a drug marketed by Taro, Glenmark Pharms Ltd, Ani Pharms Inc, Sun Pharm Inds Ltd, Jubilant Cadista, Apotex Inc, Amneal Pharms, Breckenridge Pharm, West-ward Pharms Int, and Sun Pharm Inds, and is included in eleven NDAs. It is available from twenty-two suppliers. Additional details are available on the OXCARBAZEPINE profile page.

The generic ingredient in OXCARBAZEPINE is oxcarbazepine. There are nineteen drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the oxcarbazepine profile page.

Summary for NDA: 078069

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Anticonvulsants
Formulation / Manufacturing:see details

Pharmacology for NDA: 078069

Suppliers and Packaging for NDA: 078069

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OXCARBAZEPINE
oxcarbazepine
TABLET;ORAL 078069 ANDA REMEDYREPACK INC. 49349-261 49349-261-02 30 TABLET in 1 BLISTER PACK (49349-261-02)
OXCARBAZEPINE
oxcarbazepine
TABLET;ORAL 078069 ANDA REMEDYREPACK INC. 49349-785 49349-785-02 30 TABLET in 1 BLISTER PACK (49349-785-02)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength150MG
Approval Date:Jan 11, 2008TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength300MG
Approval Date:Jan 11, 2008TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength600MG
Approval Date:Jan 11, 2008TE:ABRLD:No


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Serving 500+ biopharmaceutical companies globally:

Argus Health
Colorcon
Dow
Chubb
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Covington
Citi
Harvard Business School
Daiichi Sankyo
Medtronic

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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